Status:
TERMINATED
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
Lead Sponsor:
Radboud University Medical Center
Conditions:
Osteoradionecrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late complication of radiation therapy) of the jaw.
Detailed Description
Damage to the lower jaw as a late complication of radiation therapy (osteoradionecrosis (ORN)) is often seen in patients treated with radiation therapy for a tumor in the head and neck region. Part of...
Eligibility Criteria
Inclusion
- Informed consent
- Age ≥ 18 jr
- WHO performance status 0-2
- Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.
- Local recurrence must be ruled out
- Necrosis of the jaw with at least one of the following symptoms for over 3 month present:
- Bone exposition which measures at least 1 cm
- Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
- Non-healing extraction socket
Exclusion
- Former HBO treatment
- Contra indication for HBO treatment (pneumothorax)
- Bisphosphonate treatment in the medical history
- reirradiation in the medical history
- Osteosynthesis material in the affected area
- Distant metastasis
- Primary or recurrent tumor in the affected area
- Malignancies elsewhere
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00989820
Start Date
October 1 2009
End Date
March 1 2020
Last Update
September 15 2025
Active Locations (8)
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1
NKI/AvL
Amsterdam, Netherlands, 1066CX
2
VU University Medical centre
Amsterdam, Netherlands
3
University Medical Center Groningen
Groningen, Netherlands
4
Leiden University Medical Center
Leiden, Netherlands, 2333ZA